CDRM Study: Computer-assisted Diabetes Risk Management-for Secondary and Tertiary Prevention of T2DM Complications (CDRM_DMP)
|ClinicalTrials.gov Identifier: NCT01556529|
Recruitment Status : Completed
First Posted : March 16, 2012
Last Update Posted : March 21, 2012
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus Type 2||Procedure: risk profile information Procedure: standard DMP care|
The study will determine the effects of a computer-assisted diabetes risk management (CDRM) system on compliance and outcome. All subjects are Type 2 Diabetes Mellitus (T2DM) patients enrolled in the National T2DM Disease Management Programme (DMP) offered by the German National Health Insurance System. Of all people living in Germany 90% are insured there; more than 60% of all T2DM patients insured there are - voluntarily - enrolled in the T2DM-DMP. As in any DMP, the rationale is that by regular visits to the attending physician, strict application of National Guidelines and by keeping the patient in a narrow corridor of optimal biomedical parameters (SBP, DBP, BMI, and specific lab parameters), the probability of complications, hospitalizations and other functional impairments is minimized.
The rationale of the study is that more information on individual risk profile and its changes in the course of care will lead to more patient empowerment adding to more effective preventing the manifestation of these risks.
The Intervention Group, in addition to receiving the T2DM care standard according to the National Guidelines issued by AWMF, within the framework of the National T2DM Disease Management Programme, will receive individualized reports showing their personal risk for the characteristic T2DM complications. Reports are sent to attending general practitioners (GP) for communicating and explaining them to patients.
The CDRM system entails a combination of several telematic instruments used by the patient, GP and medical specialists. Key functionalities of the network supporting the care approach are the software integration of GP practices and an automated data recording via digital devices of blood glucose meters. Furthermore, the CDRM-Tool, Accu-Chek Mellibase a client server application of Roche Diagnostics GmbH is connected to the system.
It generates reports - one for the physician and one for the patient - on the current health status, describing the 10 year risk to develop a characteristic complication (separately for myocardial infarction, stroke, kidney failure, blindness, amputation) and the potential to reduce this risk. These reports shall be used during consultations to help doctors and patients to communicate about diabetes associated risks and individual potential. The GP report shall ease doctor's therapy decisions. The patient report shall inform the patient to improve compliance, strengthen empowerment. The CDRM system gains this information by correlating the basic patient data plus the data from recent medical findings with the most recent diabetes research evidence. GPs of this intervention group will only get advice concerning how to use the CDRM system properly, no further (extra) intervention measures are permitted. In particular, no therapy recommendations from the research team to GPs how to decide on individual therapy or medication.
The control group will receive the T2DM care standard according to the National Guidelines issued by AWMF, within the framework of the National T2DM Disease Management Programme.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||405 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||CDRM Study: Computer-assisted Diabetes Risk Management-evaluation of a Medical Care Approach to Support Secondary and Tertiary Prevention of Type 2 Diabetes Mellitus and Its Complications|
|Study Start Date :||June 2007|
|Primary Completion Date :||May 2011|
|Study Completion Date :||June 2011|
Experimental: risk profile information
patient gets information on quantitative individual complication risk profile and patient gets standard T2DM DMP care
Procedure: risk profile information
(1) patient on a regular basis receives individualized reports on his/her quantitative risk for 6 typical diabetes complications over the next 10 years, (2) standard T2DMP care, as outlined by AWMF diabetes guidelines
Other Name: risk calculatorProcedure: standard DMP care
standard disease management of T2DM care
Other Name: risk calculator
Active Comparator: Control
Control group: patient gets standard T2DM DMP care
Procedure: standard DMP care
standard disease management of T2DM care
Other Name: AWMF Guidelines oriented care
- HbA1c, incidence of typical diabetes complications [ Time Frame: 36 months (max) ]
- quantitative diabetes typical complication risk profile [ Time Frame: 36 months (max) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556529
|Philipps University Marburg Medical Center|
|Marburg, Germany, 35043|
|Principal Investigator:||Ulrich O Mueller, MD PhD||Medical School, Marburg University, Marburg, State of Hesse: Germany|